IV access port cap for providing antimicrobial protection

ABSTRACT

A cap is configured to provide antimicrobial protection to a female luer port of an intravenous device. The cap distributes an antimicrobial solution within the intraluminal surfaces of the port when the cap is connected to the port. A cap may also be designed to distribute an antimicrobial solution around the exterior surfaces of the port. Once connected to a port, the cap can form a seal that minimizes the evaporation of the antimicrobial solution from within the lumen of a port. The cap can therefore provide antimicrobial protection against another device that is connected to the port once the cap is removed.

CROSS-REFERENCE TO RELATED APPLICATIONS

Not Applicable.

BACKGROUND OF THE INVENTION

The present invention relates generally to caps for providingantimicrobial protection to an IV access port or other type of devicehaving a female luer connection. In particular, the caps of the presentinvention can be used to distribute an antimicrobial solution within theintraluminal space of a female luer device.

Currently, there are various products available for capping a port of anintravenous device (e.g. a catheter or other infusion device). In thisspecification, port will be used generally to describe any type ofconnector for interconnecting two devices. For example, FIG. 1 generallyillustrates a port 100 that is configured as a female luer lockconnector, while FIG. 2 generally illustrates a port 200 that isconfigured as a needleless female luer connector. Typically, aneedleless connector employs a valve that seals the lumen of the devicefrom the exterior environment and which is pierced or otherwiseseparated by a male connector to obtain access to the lumen.

In this specification, a female luer connector should be interpreted asany connector having an internal lumen that is tapered to conform to acorresponding male connector having the same or similar degree oftapering. These female luer connectors can include luer lock and luerslip (or non-lock luer) connectors.

Intravenous devices can employ ports to provide quick access to apatient's vasculature. These ports also enable the device to remainwithin the patient's vasculature even when no access to the vasculatureis needed. When a port of an intravenous device is not in use, it isdesirable to maintain the port clean and free from bacteria and othermicrobes. If the port becomes contaminated with microbes while not inuse, it is possible that the microbes will be flushed into the patient'svasculature once the port is again used for accessing the patient'svasculature. Accordingly, maintaining a sterile port is essential tominimize the risk of infection.

To maintain the sterility of a port, various types of caps have beendesigned. These caps typically contain an antimicrobial solution that isapplied to the exterior surfaces of the port when a cap is attached tothe port. For example, some caps employ an alcohol-soaked material thatis disposed within the cavity of the cap so that the material scrubs theexterior surfaces of the port when the cap is screwed on. Once screwedon, these caps can retain an amount of the antimicrobial solution aroundthe exterior surface of the port to ensure that the exterior surfaceremains sterile until the cap is removed.

These caps have proven to be effective for disinfecting the exteriorsurfaces of the port. However, current designs only disinfect theexterior surfaces. Any microbes that may exist within the intraluminalspace will likely remain even after these current caps are used.

Alternatively, to address this risk of infection, some ports areconfigured to have antimicrobial coatings on the intraluminal surfaces.With such coatings, the intraluminal surfaces can remain sterile even ifmicrobes come in contact with the surfaces. These coatings can alsodissolve into the fluid within the lumen to effectively spreadantimicrobial agents throughout the lumen. However, there are variousdrawbacks to using antimicrobial coatings on the intraluminal surfacesof ports. For example, ports that employ antimicrobial coatings aresignificantly more expensive to produce. As a result many facilitieschoose not to use them. Also, for a coating to be effective, it mustretain its antimicrobial properties for at least the amount of time thatthe port could possibly be used (e.g. up to 7 days). To accomplish this,relatively thick coatings or highly concentrated coatings are used. Thiscauses the concentration of antimicrobial agents to be very high duringthe initial usage time which poses a toxicity risk.

BRIEF SUMMARY OF THE INVENTION

The present invention extends to caps for providing antimicrobialprotection to a female luer port of an intravenous device. The caps ofthe present invention are designed to distribute an antimicrobialsolution within the intraluminal surfaces of the port. Additionally, insome embodiments, the caps are designed to also distribute anantimicrobial solution around the exterior surfaces of the port.Accordingly, the caps of the present invention provide a completesolution for disinfecting a port of an intravenous device.

In one embodiment, the present invention is implemented as a cap for aport of an intravenous device. The cap can comprise a body having acavity; an actuator positioned within the cavity; and an absorbentmaterial containing an antimicrobial solution. The absorbent material iscontained within the cavity between the actuator and an inner surface ofthe body. When the cap is connected to a port of an intravenous device,the actuator is forced into the cavity and compresses the absorbentmaterial causing the antimicrobial solution to flow onto an intraluminalsurface of the port.

In some embodiments, the actuator comprises a lumen through which theantimicrobial solution flows to reach a lumen of the port.

In some embodiments, the actuator comprises a male luer in which thelumen is formed.

In some embodiments, the antimicrobial solution flows through a gapbetween the body and an exterior surface of the actuator and onto anexterior surface of the port.

In some embodiments, the body includes a seal that the actuator contactswhen the cap is connected to the port thereby forming a seal between theactuator and the body.

In some embodiments, the concentration of an antimicrobial agent withinthe antimicrobial solution is selected such that when the antimicrobialsolution mixes with fluid contained within the lumen of the port, theconcentration of the antimicrobial agent remains higher than the minimuminhibitory concentration of the antimicrobial agent.

In some embodiments, the port is a female luer into which the actuatorinserts.

In some embodiments, the port is a needleless connector into which theactuator inserts.

In some embodiments, the actuator includes a protrusion that ispositioned within a lumen in the body, the protrusion having a lumenthrough which the antimicrobial solution flows.

In some embodiments, the actuator includes a plurality of prongs thatextend through corresponding openings in the body.

In some embodiments, the antimicrobial solution flows through theopenings when the actuator is forced into the cavity.

In some embodiments, the actuator includes a lumen that has anantimicrobial coating.

In another embodiment, the present invention is implemented as a cap fora port of an intravenous device. The cap can comprise a body having acavity; an actuator positioned within the cavity, the actuator having alumen; and an absorbent material containing an antimicrobial solution,the absorbent material being contained within the cavity between theactuator and an inner surface of the body. Prior to the cap beingconnected to a port of an intravenous device, the absorbent materialremains uncompressed. Then, when the cap is connected to a port of anintravenous device, the actuator compresses the absorbent materialcausing the antimicrobial solution to flow through the lumen of theactuator and into a lumen of the port.

In some embodiments, the actuator is sized such that a gap existsbetween an outer edge of the actuator and a wall of the cavity, theantimicrobial solution also flowing through the gap onto an exteriorsurface of the port.

In some embodiments, the actuator includes a plurality of prongs whichextend through corresponding openings in the body. The antimicrobialsolution flows through the openings onto the exterior surface of theport

In some embodiments, the body includes a seal for sealing the lumen ofthe actuator.

In some embodiments, the actuator comprises a male luer.

In another embodiment, the present invention is implemented as a cap fora needleless connector of an intravenous device. The cap can comprise abody having a cavity; an absorbent material positioned within thecavity, the absorbent material containing an antimicrobial solution; andan actuator positioned within the cavity against the absorbent material.The actuator is moveable within the cavity to compress the absorbentmaterial such that upon the cap being connected to a needlelessconnector, the needleless connector causes the actuator to compress theabsorbent material releasing the antimicrobial solution onto anintraluminal surface of the needleless connector.

In some embodiments, the actuator comprises a lumen. The antimicrobialsolution flows through the lumen of the actuator onto the intraluminalsurface of the needleless connector.

In some embodiments, the antimicrobial solution also flows around anexterior surface of the actuator onto an exterior surface of theneedleless connector.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter.

Additional features and advantages of the invention will be set forth inthe description which follows, and in part will be obvious from thedescription, or may be learned by the practice of the invention. Thefeatures and advantages of the invention may be realized and obtained bymeans of the instruments and combinations particularly pointed out inthe appended claims. These and other features of the present inventionwill become more fully apparent from the following description andappended claims, or may be learned by the practice of the invention asset forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of the invention can be obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof which areillustrated in the appended drawings. Understanding that these drawingsdepict only typical embodiments of the invention and are not thereforeto be considered to be limiting of its scope, the invention will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIG. 1 illustrates a perspective view of an example of a prior art portthat is configured as a female luer lock connector.

FIG. 2 illustrates a perspective view of an example of a prior art portthat is configured as a needleless female luer connector.

FIG. 3 illustrates a perspective view of a cap in accordance with one ormore embodiments of the invention that may be used to apply anantimicrobial solution to the intraluminal surfaces of a port.

FIG. 4 illustrates a cross-sectional view of a cap in accordance withone or more embodiments of the invention in which an actuator is movablewithin the body of the cap to cause an antimicrobial solution to besqueezed from an absorbent material contained within the body anddistributed through the actuator into the intraluminal space of a port.

FIG. 5 illustrates a cross-sectional view of a cap having a body that iscomprised of two pieces in accordance with one or more embodiments ofthe invention.

FIG. 6 illustrates a cross-sectional view of a cap that is configured tobe connected to a port that is configured as a luer slip connector inaccordance with one or more embodiments of the invention.

FIGS. 7A-7C illustrate a sequence of how the cap depicted in FIG. 4 isconnected to a port of an intravenous device. FIG. 7A illustrates thecap prior to contacting the port. FIG. 7B illustrates that, as the capis being forced onto the port, the actuator is forced into the absorbentmaterial causing antimicrobial solution to flow towards the port throughthe gaps formed by the movement of the actuator and through the lumen ofthe actuator. FIG. 7C illustrates that, once the cap is fully connectedto the port, the actuator is forced against a seal to seal the lumen ofthe port.

FIG. 8 illustrates a cross-sectional view of the cap depicted in FIG. 4when connected to a port that does not include a ridge against which theactuator presses.

FIGS. 9A and 9B illustrate a sequence of how the cap depicted in FIG. 4can be used on a port that employs a septum.

FIG. 10A illustrates a cross-sectional view of an alternate embodimentof a cap which employs prongs to facilitate the flow of antimicrobialsolution to the exterior surfaces of the port.

FIG. 10B illustrates an exploded view of the cap of FIG. 10A.

FIGS. 11A-11C illustrate a sequence of how the cap depicted in FIG. 10Ais connected to a port of an intravenous device. FIG. 11A illustratesthe cap upon contacting the port. FIG. 11B illustrates that, as the capis being forced onto the port, the actuator is forced into the absorbentmaterial causing antimicrobial solution to flow towards the port throughthe gaps formed by the movement of the actuator and through the lumen ofthe actuator. FIG. 11C illustrates that, once the cap is fully connectedto the port, the actuator is forced against a seal to cause further flowof the antimicrobial solution to be only through the lumen of theactuator.

DETAILED DESCRIPTION OF THE INVENTION

The present invention extends to caps for providing antimicrobialprotection to a female luer port of an intravenous device. The caps ofthe present invention are designed to distribute an antimicrobialsolution within the intraluminal surfaces of the port. Additionally, insome embodiments, the caps are designed to also distribute anantimicrobial solution around the exterior surfaces of the port.Accordingly, the caps of the present invention provide a completesolution for disinfecting a port of an intravenous device.

In one embodiment, the present invention is implemented as a cap for aport of an intravenous device. The cap can comprise a body having acavity; an actuator positioned within the cavity; and an absorbentmaterial containing an antimicrobial solution. The absorbent material iscontained within the cavity between the actuator and an inner surface ofthe body. When the cap is connected to a port of an intravenous device,the actuator is forced into the cavity and compresses the absorbentmaterial causing the antimicrobial solution to flow onto an intraluminalsurface of the port.

In some embodiments, the actuator comprises a lumen through which theantimicrobial solution flows to reach a lumen of the port.

In some embodiments, the actuator comprises a male luer in which thelumen is formed.

In some embodiments, the antimicrobial solution flows through a gapbetween the body and an exterior surface of the actuator and onto anexterior surface of the port.

In some embodiments, the body includes a seal that the actuator contactswhen the cap is connected to the port thereby forming a seal between theactuator and the body.

In some embodiments, the concentration of an antimicrobial agent withinthe antimicrobial solution is selected such that when the antimicrobialsolution mixes with fluid contained within the lumen of the port, theconcentration of the antimicrobial agent remains higher than the minimuminhibitory concentration of the antimicrobial agent.

In some embodiments, the port is a female luer into which the actuatorinserts.

In some embodiments, the port is a needleless connector into which theactuator inserts.

In some embodiments, the actuator includes a protrusion that ispositioned within a lumen in the body, the protrusion having a lumenthrough which the antimicrobial solution flows.

In some embodiments, the actuator includes a plurality of prongs thatextend through corresponding openings in the body.

In some embodiments, the antimicrobial solution flows through theopenings when the actuator is forced into the cavity.

In some embodiments, the actuator includes a lumen that has anantimicrobial coating.

In another embodiment, the present invention is implemented as a cap fora port of an intravenous device. The cap can comprise a body having acavity; an actuator positioned within the cavity, the actuator having alumen; and an absorbent material containing an antimicrobial solution,the absorbent material being contained within the cavity between theactuator and an inner surface of the body. Prior to the cap beingconnected to a port of an intravenous device, the absorbent materialremains uncompressed. Then, when the cap is connected to a port of anintravenous device, the actuator compresses the absorbent materialcausing the antimicrobial solution to flow through the lumen of theactuator and into a lumen of the port.

In some embodiments, the actuator is sized such that a gap existsbetween an outer edge of the actuator and a wall of the cavity, theantimicrobial solution also flowing through the gap onto an exteriorsurface of the port.

In some embodiments, the actuator includes a plurality of prongs whichextend through corresponding openings in the body. The antimicrobialsolution flows through the openings onto the exterior surface of theport

In some embodiments, the body includes a seal for sealing the lumen ofthe actuator.

In some embodiments, the actuator comprises a male luer.

In another embodiment, the present invention is implemented as a cap fora needleless connector of an intravenous device. The cap can comprise abody having a cavity; an absorbent material positioned within thecavity, the absorbent material containing an antimicrobial solution; andan actuator positioned within the cavity against the absorbent material.The actuator is moveable within the cavity to compress the absorbentmaterial such that upon the cap being connected to a needlelessconnector, the needleless connector causes the actuator to compress theabsorbent material releasing the antimicrobial solution onto anintraluminal surface of the needleless connector.

In some embodiments, the actuator comprises a lumen. The antimicrobialsolution flows through the lumen of the actuator onto the intraluminalsurface of the needleless connector.

In some embodiments, the antimicrobial solution also flows around anexterior surface of the actuator onto an exterior surface of theneedleless connector.

FIG. 3 illustrates a perspective view of a cap 300 in accordance withone or more embodiments of the invention. As shown, cap 300 comprises abody 301 and an actuator 302. Body 301 is generally shaped to allow cap300 to be connected to a female luer connector such as port 100. If thecap is designed to connect to a female luer lock connector, the insidesurface of the body can include threads (e.g. as shown in FIG. 4). Incontrast, if the cap is designed to connect to a female luer slipconnector, the inside surface of the body may or may not includethreads. In either case, actuator 302 can be configured as a male luerconnector to allow actuator 302 to be inserted into the female luer port100.

FIG. 4 illustrates a cross-section view of cap 300. As shown, cap 300includes body 301, actuator 302, and absorbent material 303 positionedbetween body 301 and actuator 302. Cap 300 includes threads 310 and istherefore an example of a cap designed for a female luer lock connector.Actuator 302 has a tip that is designed as a male luer connector toallow the tip to be inserted into the lumen of a female luer connector.

FIG. 4 depicts cap 300 prior to being connected to a port. Beforeconnection, actuator 302 is positioned against the interior surface ofbody 301 and does not compress absorbent material 303. In someembodiments, actuator 302 can be held in this position by an adhesive,welding, or other physical force between body 301 and actuator 302. Inother embodiments, actuator 302 can be held in this position byabsorbent material 303. In other words, absorbent material 303 may besufficiently rigid to retain the position of actuator 302 until asubstantial force is applied against actuator 302. In any case, actuator302 is designed to not compress absorbent material 303 until cap 300 isconnected to a port. A seal (not shown) can be applied overtop ofactuator 302 and possibly the opening of body 301 to seal absorbentmaterial 303 from the exterior environment until cap 300 is to be used.

FIG. 5 illustrates a cross-sectional view of an alternate embodiment ofcap 300. In this alternate embodiment, body 301 comprises two pieces, atop piece 301 a and a bottom piece 301 b. This two piece design can beused to facilitate manufacturing (e.g. to facilitate positioningactuator 302 within body 301). Whether the design of FIG. 4 or of FIG. 5is employed, cap 300 will function the same as will be described below.

FIG. 6 illustrates a cross-sectional view of another alternateembodiment of cap 300. In this embodiment, body 301 does not includethreads but is configured to form a friction fit with the exteriorsurface of a port. Accordingly, a cap in accordance with this alternateembodiment could be used on a non-lock female luer connector. Regardlessof the type of port to which cap 300 will be connected, it is desirableto secure body 301 to the port (e.g. via threads or a friction fit) toallow a seal to be formed between actuator 302 and body 301 once the capis connected. The role of this seal will be further described below withreference to FIG. 7C.

With continued reference to FIGS. 4-6, absorbent material 303 issaturated with an antimicrobial solution which remains within absorbentmaterial 303 until absorbent material 303 is compressed. Actuator 302 isdesigned to provide a fluid pathway to distribute the antimicrobialsolution to a port when cap 300 is connected to the port. The primaryfluid pathway is through lumen 320. However, a secondary fluid pathwayis also provided around the exterior of actuator 302. The distributionof the antimicrobial solution is illustrated in FIGS. 7A-7C.

FIGS. 7A-7C illustrate a sequence that occurs when cap 300 is connectedto a port. Although FIGS. 7A-7C illustrate the design of cap 300 asshown in FIG. 4, the same sequence would occur when a cap designed asshown in FIG. 5 or 6 is connected. Also, for simplicity of illustration,cap 300 is shown as being connected to port 100. However, the samesequence would occur when cap 300 is connected to any port that isconfigured as a female luer connector. Examples of ports on which cap300 can be used include the BD Q-Syte® (manufactured by Becton,Dickinson and Company), the CareFusion MaxPlus® Clear (manufactured byCareFusion Corp), and the LifeShield MicroClave® (manufactured byHospira, Inc.) among many others.

FIG. 7A shows the state of cap 300 prior to contacting port 100. In thisstate, cap 300 is as shown in FIG. 4. Port 100 is shown as including aninternal ridge 111 against which the tip of actuator 302 presses whencap 300 is connected to the port. Port 100 is also shown as includingthreads 110 and is therefore an example of a luer lock connector.Accordingly, cap 300 is connected to port 100 by threading the cap ontothe port.

As shown in FIG. 7B, as cap 300 is initially inserted into and advancedonto port 100, the tip of actuator 302 contacts ridge 111 of port 100.This contact forces actuator upward away from body 301 and intoabsorbent material 303. The compression of absorbent material 303 causesthe antimicrobial solution to flow out of the absorbent material. Thearrows in FIG. 7B indicate the pathways along which the absorbentmaterial will flow.

The primary pathway along which the antimicrobial solution flows isthrough lumen 320 of actuator 302. Because lumen 320 aligns with lumen120 of port 100, the antimicrobial solution flowing through lumen 320will ultimately be distributed along the surfaces of lumen 120 and intoany fluid contained within lumen 120. In this way, the intraluminalsurfaces of port 100 can be disinfected.

The secondary pathway is around actuator 302 as depicted by the outerarrows in FIG. 7B. The antimicrobial solution will flow along thesecondary pathway until the top surface of actuator 302 contacts seal304 formed along the interior surface of body 301 as is shown in FIG.7C. The contact between actuator 302 and seal 304 limits theantimicrobial solution from flowing around actuator 302 and thereforeforces further flow through lumen 320. In this way, an adequate amountof antimicrobial solution will flow into the intraluminal space of port100.

As shown in FIG. 7C, after cap 300 has been connected, antimicrobialsolution will be contained within lumen 320 and lumen 120 as well as inthe spaces between the outer surface of actuator 302, and the innersurface of body 301. This antimicrobial solution outside of actuator 302can disinfect the top and outer surfaces of port 100. Because theconnection between port 100 and cap 300 may not be fluid tight, theantimicrobial solution may be allowed to seep between threads 110 and310 and onto the exterior surfaces of port 100. Also, in someembodiments where a tight seal is not formed (or at least not formedinitially when the antimicrobial solution flows around actuator 302)this antimicrobial solution can flow into the opening of port 100between the exterior surface of actuator 302 and the interior surface ofport 100. In this way, the intraluminal surfaces that may otherwise notbe reached by antimicrobial solution that has flowed through lumen 320may still be disinfected.

Accordingly, the design of cap 300 allows the intraluminal surfaces of aport to be disinfected. Because the lumen of port 100 may typicallycontain a fluid (e.g. a saline solution or other solution that wasinfused into the patient), the antimicrobial solution can mix with thefluid to enhance the distribution of the antimicrobial agents throughoutlumen 120.

When cap 300 is fully connected to port 100, a seal can be formedbetween actuator 302 and seal 304 as shown in FIG. 7C. The tight fitbetween the male luer actuator 302 and the female luer port 100 can alsoform a seal between these two connectors. Accordingly, lumens 120 and320 can be substantially sealed from the external environment therebylimiting the amount of antimicrobial solution within lumen 120 thatevaporates after cap 300 has been connected. The antimicrobial solutioncan therefore remain active until the cap is removed for attachment ofanother device. In this way, when another device is connected to theport, the antimicrobial solution that remains within lumen 120 candisinfect the tip of the device. Accordingly, cap 300 not onlydisinfects port 100 when not in use, but can also disinfect otherdevices that are connected to the port after cap 300 has been removed.

FIG. 8 illustrates a cross-sectional view of an alternate embodiment inwhich a port 100 a does not include a ledge against which the tip ofactuator 302 presses. In such cases, the frictional force created whenactuator 302 has been inserted into lumen 120 can be sufficient to forceactuator 302 upward into absorbent material 303. This frictional forcecan also be sufficient to form a seal between actuator 302 and port 100.

FIGS. 9A and 9B illustrate a cross-sectional view of another alternateembodiment in which cap 300 is connected to a port 200 that isconfigured as a needleless connector that includes a split septum 230.As shown in FIG. 9A, as the tip of actuator 302 initially contactsseptum 230 and is forced through septum 230, actuator 302 is forcedupwardly to initiate the flow of antimicrobial solution. Actuator 302will pass through septum 230 and ultimately contact a ledge within lumen220 of port 200 (or if port 200 does not contain a ledge, may contactthe tapered sides of the port). As shown in FIG. 9B, when fullyconnected, cap 300 is positioned in a similar manner on port 200 as cap300 is positioned on port 100. Accordingly, cap 300 can be used todisinfect the intraluminal surfaces of ports of various designs andconfigurations.

FIG. 10A illustrates a cross-sectional view of another embodiment of acap 1000. Cap 1000, like cap 300, includes a body 1001, an actuator1002, and absorbent material 1003. However, actuator 1002 and the bottomsurface of body 1001 have a different configuration to enhance the flowof antimicrobial solution to the exterior surfaces of a port.

FIG. 10B illustrates a cross-sectional exploded view of cap 1000 inwhich actuator 1002 is shown removed from body 1001. As shown, actuator1002 includes a central protrusion 1053 that forms lumen 1020. Actuator1002 also includes prongs 1052 that extend from the bottom surface ofactuator 1002. The bottom of body 1001 is configured to accommodateactuator 1002. For example, body 1001 includes a lumen 1050 within whichprotrusion 1053 is contained and openings 1051 through which prongs 1052extend. FIGS. 11A-11C illustrate how this configuration of cap 1000enhances the flow of antimicrobial solution to the exterior surfaces ofa port while still distributing sufficient antimicrobial solution to thelumen of the port.

FIG. 11A illustrates cap 1000 upon actuator 1002 contacted the topsurface of port 1100. As shown, the design of actuator 1002 causesprongs 1052 to first contact port 1100. Then, in FIG. 11B, the upwardforce on prongs 1052 causes actuator 1002 to compress absorbent material1003 resulting in antimicrobial solution flowing through lumen 1020 andaround the exterior of actuator 1002 in much the same manner asdescribed with reference to FIG. 7B.

However, because of the positioning of openings 1051 near the edges ofport 1100, the antimicrobial solution that flows through openings 1051will more easily flow onto the exterior surfaces of port 1100.Additionally, as with cap 300, the primary pathway of the flow of theantimicrobial solution is through lumen 1020 and into lumen 1120 of port1100.

FIG. 11C illustrates cap 1000 once fully connected to port 1100. Asshown, in this position, port 1100 has forced actuator 1002 upward untilit contacts seal 1004. At this point, antimicrobial solution will beforced to flow through lumen 1020. However, the antimicrobial solutionthat flowed around actuator 1002 and is contained within the internalspaces of body 1001 will be allowed to flow out through openings 1051onto the exterior surfaces of port 1100.

Although FIG. 11C shows that a gap exists between protrusion 1053 andthe internal surfaces of lumen 1050 when cap 1000 is fully connected, insome embodiments, the dimensions of protrusion 1053 and lumen 1050 canbe configured so that protrusion 1053 forms a tight seal within lumen1050 when actuator 1002 is in the upward position. Forming a sealbetween protrusion 1053 and lumen 1050 may be desired when a tight sealis not formed between port 1100 and body 1001.

The caps of the present invention also provide the advantage ofminimizing the concentrations of antimicrobial solution that must beused to ensure that the port is adequately disinfected. For example, asstated in the Background, one problem that arises when antimicrobialcoatings are used is that the coatings may be too concentrated and maytherefore pose toxicity problems. In contrast, because the caps of thepresent invention are intended for one-time use and are deployed whenthe port is not in use, the concentrations of antimicrobial solution canbe minimized. In other words, in contrast to coatings which must remainactive from the time they are applied to the port (e.g. whenmanufactured) until the port will no longer be used, the caps of thepresent invention will only remain on the port in between uses. Becausethe fluid volume in the port is static and fixed, the concentration ofthe antimicrobial solution will not change when the cap is in place.Therefore a reduced concentration of antimicrobial solution can beemployed in the caps of the present invention while still providingadequate antimicrobial protection. In some embodiments, theconcentration of the antimicrobial solution (or the concentration oncemixed with fluid already present within the lumen of the port) can bejust higher than the minimum inhibitory concentration of theantimicrobial agent in the solution.

Many different types of antimicrobial solutions may be used in caps ofthe present invention. For example, any antimicrobial agent that issoluable in alcohol, saline, or saline/heparin solutions can beemployed. The concentration of the antimicrobial agent within theantimicrobial solution can be selected so that the resultingconcentration of the agent once the antimicrobial solution is mixed withthe fluid in the lumen of the port is above the minimum inhibitoryconcentration of the antimicrobial agent. Suitable antimicrobial agentsinclude CHA and CHG among others.

In alternate embodiments, the lumen of the actuator can be coated withan antimicrobial coating. In such embodiments, the cap may or may notalso include the absorbent material containing the antimicrobialsolution. For example, when the cap does not include the absorbentmaterial, the antimicrobial protection can be provided when the fluidwithin the lumen of the port contacts the antimicrobial coating withinthe lumen of the actuator. The dry antimicrobial coating can dissolveinto the fluid to thereby disinfect the lumen of the port. Providing anantimicrobial coating on the lumen of the actuator as opposed to on thelumen of the port can allow a lower concentration of antimicrobial agentto be used for the reasons described above.

When the cap does include the absorbent material and an antimicrobialcoating, the flow of the antimicrobial solution from the absorbentmaterial may be partially or completely directed around the exterior ofthe actuator to ensure distribution on the exterior surfaces of theport. Some antimicrobial solution may be designed to flow through thelumen in the actuator to assist in distributing the antimicrobialcoating throughout the lumen of the port. In this way, an antimicrobialsolution can still be directed to both the intraluminal and the exteriorsurfaces of the port.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

The invention claimed is:
 1. A cap for a port of an intravenous device,the cap comprising: a body having a proximal end and a distal end, thebody including a cavity formed in the distal end of the body; anactuator having a proximal end and a distal end, the proximal end of theactuator being contained within the cavity, the distal end of theactuator extending out from the cavity and being configured to insertinto the port of the intravenous device, the proximal end of theactuator being configured to move within the cavity between a distalposition and a proximal position; and an absorbent material containingan antimicrobial solution, the absorbent material being contained withinthe cavity between the proximal end of the body and the proximal end ofthe actuator, the absorbent material being compressible; wherein whenthe cap is connected to the port of the intravenous device, the proximalend of the actuator is advanced proximally into the cavity from thedistal position to the proximal position thereby compressing theabsorbent material causing the antimicrobial solution to flow throughthe distal end of the actuator and onto an intraluminal surface of theport.
 2. The cap of claim 1, wherein the distal end of the actuatorcomprises a lumen, the antimicrobial solution flowing through the lumeninto a lumen of the port.
 3. The cap of claim 2, wherein the distal endof the actuator comprises a male luer in which the lumen is formed. 4.The cap of claim 1, wherein the proximal end of the actuator isconfigured such that a gap exists between the proximal end of theactuator and an inner surface of the cavity as the proximal end of theactuator is advanced towards the proximal position, and wherein theantimicrobial solution flows through the gap and onto an exteriorsurface of the port.
 5. The cap of claim 1, wherein, when in theproximal position, the proximal end of the actuator contacts an innersurface of the cavity thereby forming a seal between the actuator andthe body.
 6. The cap of claim 1, wherein the concentration of anantimicrobial agent within the antimicrobial solution is selected suchthat when the antimicrobial solution mixes with fluid contained withinthe lumen of the port, the concentration of the antimicrobial agentremains higher than the minimum inhibitory concentration of theantimicrobial agent.
 7. The cap of claim 1, wherein the port is a femaleluer into which the distal end of the actuator inserts.
 8. The cap ofclaim 1, wherein the port is a needleless connector into which thedistal end of the actuator inserts.
 9. The cap of claim 1, wherein thedistal end of the body forms a lumen, and wherein the distal end of theactuator forms a protrusion that is positioned within the lumen formedby the distal end of the body, the protrusion having a lumen throughwhich the antimicrobial solution flows.
 10. The cap of claim 9, whereinthe actuator includes a plurality of prongs that extend throughcorresponding openings in the distal end of the body.
 11. The cap ofclaim 10, wherein the antimicrobial solution flows through the openingswhen the proximal end of the actuator is advanced proximally into thecavity.
 12. The cap of claim 1, wherein the distal end of the actuatorincludes a lumen, the lumen having an antimicrobial coating.
 13. A capfor a port of an intravenous device, the cap comprising: a body having aproximal end and a distal end, the body including a cavity formed in thedistal end of the body; an actuator having a proximal end and a distalend, the proximal end of the actuator being contained within the cavity,the distal end of the actuator extending out from the cavity and beingconfigured to insert into the port of the intravenous device, the distalend of the actuator including a lumen, the proximal end of the actuatorbeing configured to move within the cavity between a distal position anda proximal position; and an absorbent material containing anantimicrobial solution, the absorbent material being contained withinthe cavity between the proximal end of the actuator and an inner surfaceof the body; wherein prior to the cap being connected to the port of theintravenous device, the absorbent material remains uncompressed, andwhen the cap is connected to the port of the intravenous device, theactuator compresses the absorbent material causing the antimicrobialsolution to flow through the lumen of the distal end of the actuator andinto a lumen of the port.
 14. The cap of claim 13, wherein the proximalend of the actuator is sized such that a gap exists between an outeredge of the proximal end of the actuator and a wall of the cavity, theantimicrobial solution also flowing through the gap onto an exteriorsurface of the port.
 15. The cap of claim 14, wherein the actuatorincludes a plurality of prongs which extend through correspondingopenings in the body, the antimicrobial solution flowing through theopenings onto the exterior surface of the port.
 16. The cap of claim 13,wherein, when in the proximal position, the proximal end of the actuatorforms a seal with an inner surface of the cavity.
 17. The cap of claim13, wherein the distal end of the actuator comprises a male luer.
 18. Acap for a needleless connector of an intravenous device, the capcomprising: a body having a proximal end and a distal end, the bodyincluding a cavity formed in the distal end of the body; an absorbentmaterial positioned within the cavity, the absorbent material containingan antimicrobial solution; and an actuator having a proximal end and adistal end, the proximal end of the actuator being contained within thecavity, the distal end of the actuator extending out from the cavity andbeing configured to insert into the needleless connector, the proximalend of the actuator being configured to move within the cavity between adistal position and a proximal position such that upon the cap beingconnected to the needleless connector, the needleless connector causesthe proximal end of the actuator to compress the absorbent materialthereby releasing the antimicrobial solution onto an intraluminalsurface of the needleless connector.
 19. The cap of claim 18, whereinthe distal end of the actuator comprises a lumen, the antimicrobialsolution flowing through the lumen of the distal end of the actuator andonto the intraluminal surface of the needleless connector.
 20. The capof claim 19, wherein the antimicrobial solution also flows around anexterior surface of the proximal end of the actuator and onto anexterior surface of the needleless connector.